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STANDARDS FOR MATERNAL CARE IN KENYA DECEMBER 2002

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Ministry of Health

STANDARDS FOR MATERNAL CARE IN KENYA

DECEMBER 2002

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COLLABORATION OF PROFESSIONAL SOCIETIES OF KENYA AND THE UNITED

KINGDOM

Royal College of Obstetricians & Gynaecologists

THE PROFESSIONAL SOCIETIES OF KENYA AND THE UNITED KINGDOM ARE COMMITTED TO DEVELOPING STANDARDS FOR MATERNAL CARE

IN KENYA THROUGH PARTNERSHIP.

ISBN 9966 – 9755 – 1 - 9

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Acknowledgement: Mary Njambi*

*(not real name) For use of cover portrait

ISBN 9966 – 9755 – 1 – 9 National Joint Steering Committee for Maternal Health Kenya 2002 Coordinators: Kenya Obstetricians and Gynaecologists Society P.O. Box 19459 Nairobi Kenya. National Nurses Association of Kenya P.O. Box 49422 Nairobi Kenya. Other collaborating partners in Kenya and UK can be contacted through the above associations. Any part of this document may be copied or adapted to meet local needs without permission, provided that the parts copied are distributed free. Any commercial reproduction requires prior permission from the National Joint Steering Committees of Kenya and the UK who would appreciate receiving a copy of any materials in which portions of the document are used.

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STANDARDS FOR MATERNAL CARE IN KENYA

KEY POINTS

1. These Standards will assist in improving the quality of maternal care and form the basis

for Clinical Audit. Evaluation of clinical practice and implementation of necessarychanges will help improve pregnancy outcome.

2. These Standards are focussed around aspects of emergency obstetric care and were

developed for all levels of health care provision in Kenya through discussion with amultidisciplinary group of health care providers.

3. Wherever possible it is recommended that the “Standards for Maternal Care” manual be

used in conjunction with the Audit Manual. 4. It is hoped that improved quality of care will increase accessibility, improve utilisation

and client satisfaction and thus help to reduce maternal and perinatal mortality andmorbidity.

First Edition December 2002

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Standards for Maternal Care

TABLE OF CONTENTS PREFACE … … … … … … … … … … … i

FOREWORD … …. … … … … … … … … … ii

ACKNOWLEDGEMENTS … … … … … … … … … … iii

EXECUTIVE SUMMARY … … … … … … … … … … iv

LIST OF ABBREVIATIONS AND ACRONYMS … … … … … … … v

DEFINITIONS … … … … … … … … … … … vi

CHAPTER 1 BACKGROUND… … … … … … … … … … … 1

1.1 Introduction … … … … … … … … … … … 1

1.2 Rationale … … … … … … … … … … … 2

1.3 Standards … … … … … … … … … … … 2

CHAPTER 2 RESOURCES FOR PROVISION OF EMERGENCY OBSTETRIC CARE… … … … 5 CHAPTER 3 STANDARDS OF CARE WITH STRUCTURE, PROCESS AND OUTCOME CRITERIA… … 7

3A. General Standards of Care … … … … … … … … … 7

3B. Haemorrhage … … … … … … … … … … … 12

3C. Infection and Sepsis… … … … … … … … … … 17

3D. (Pre-) Eclampsia… …. … … … … … … … … … 20

3E. Prolonged and Obstructed Labour … … … … … … … … 24

3F. Abortion … … … … … … … … … … … 27

CHAPTER 4 CLINICAL AUDIT … … … … … … … … … … 29

What is Clinical Audit… … … … … … … … … … 29

The Process of Clinical Audit … … … … … … … … … 30

Is Clinical Audit Different From Research? … … … … … … … 32

REFERENCES … … … … … … … … … … … 33

APPENDICES … … … … … … … … … … … 35

Appendix 1 - Kenya Quality Model (KQM)… … … … … … … … 35

Appendix 2 - Details of Equipment … … … … … … … … … 36

Appendix 3 - Contributors … … … … … … … … … … 38

Appendix 4 - Emergency Tray with Comprehensive List of Supplies & Equipment… … … 40

Professional Associations of Kenya and UK

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Standards for Maternal Care

PREFACE The “Know-How” Project was conceived in Kenya in 1998. One of the purposes of this project is to demonstrate the capacity of professional midwifery, nursing and medical organisations to play a strategic role in the provision of maternal health care through partnership within and between countries. The Standards presented here were developed by a multidisciplinary group of participants under the guidance of the Kenya and United Kingdom Steering Groups and Technical Resource Persons. Standards in this document focus on Emergency Obstetric Care provided by both hospitals and health centres. The Standards are presented in the form of an Objective followed by Structure, Process and Outcome criteria. Structure criteria describe what is needed to achieve the objective, Process criteria outline what needs to be done and Outcome criteria refer to anticipated results of achieving the objectives outlined. It is envisaged that these Standards will form the basis for Clinical Audit. Evaluation of practice together with implementation of changes needed to achieve the objectives will help improve quality of care provided. It is hoped that improved quality of care will increase clients’ and provide satisfaction as well as accessibility and use of services and thus help to reduce maternal and perinatal mortality and morbidity. Coordinators, Kenya Steering Group Dr. Joseph Karanja Mrs. Evelyn Mutio Technical Resource Persons Dr. Edwin Were Mrs. Shehnavaz S. Talib Dr. Nynke van den Broek Mrs. Gillian Barber This Manual was collated by: Dr. N. Broek (RCOG) Ms. G. Barber (RCM) Mrs. S. Talib (NNAK) Dr. E. Were (KOGS) Ms. C. Warren (Population Council) Dr. E. Muia (Population Council) Mr. W. Liambila (Population Council)

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Standards for Maternal Care

FOREWORD

The Standards for Maternal Care in Kenya 2002 marks the outcome of partnership between the Ministry of Health and health Professional Associations of Kenya and the United Kingdom to improve quality of maternal care in line with the Kenya Quality Model. On behalf of the Department of Standards and Regulatory Services, I thank DFID for providing financial resources, which enabled this partnership to develop the Standards for Maternal Care in Kenya 2002. It is now feasible for health workers at all levels of the health care delivery system in Kenya to have evidence-based Standards and guidelines to assist in the management of obstetric emergencies like Haemorrhage, Sepsis, Pregnancy Induced Hypertension, Obstructed Labour and Abortion. To be effective, additional resources are needed to disseminate these Standards to all health centres and hospitals in the country. The publication of the guidelines is only one of the critical milestones in the delivery of quality maternal services. By ensuring effective dissemination, the guidelines will contribute to better maternal services. A recent national assessment of health Standards in Kenya has identified availability and use of Standards and guidelines, staff productivity and financial management as priority areas for improvement if we are to ensure quality health care in the country. The Standards for Maternal Care in Kenya 2002 is therefore a major step in improving quality of health care in the country. I congratulate all the contributors and all those who directly or indirectly contributed to the success of this initiative. DR. TOM MBOYA OKEYO, MBchB MPH HEAD, DEPARTMENT OF STANDARDS AND REGULATORY SERVICES; MINISTRY OF HEALTH, KENYA OCTOBER 2002

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ACKNOWLEDGMENTS

The process of developing this document benefited from wide consultation with individuals and institutions in Kenya and United Kingdom. The assistance, comments, cooperation and time given by all institutions and the contributors was invaluable. In particular, we would like to acknowledge the input of the National Joint Steering Committee (NJSC) which is made up of members from the Kenya Obstetrical and Gynaecological Society (KOGS), the National Nurses Association of Kenya (NNAK), the Kenya Clinical Officers Association (KCOA), the Ministry of Health (MOH) and Population Council. In the United Kingdom, the document benefited from the assistance of the UK Steering Group, consisting of members of the Royal College of Obstetricians and Gynaecologists (RCOG), the Royal College of Midwives (RCM) and the Royal College of Nursing (RCN). The Department for International Development (DFID) is acknowledged for supporting the development of these Standards for Maternal Care in Kenya through the Safe Motherhood Know How Project.

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Standards for Maternal Care

EXECUTIVE SUMMARY

High maternal mortality is an issue of concern in Kenya. The current maternal mortality ratio is estimated at approximately 590/100 000. Many maternal and perinatal deaths could be averted if more women had access to quality obstetric care for life threatening complications of pregnancy, childbirth and the puerperium. A number of needs assessments carried out by the Government of Kenya, including the Kenya Service Provision Assessment (KSPA), the Kenya Demographic Health Survey (KDHS), those by the World Health Organisation (WHO) and UN Population Fund (UNFPA) and Population Council have identified the non use of standards and guidelines as a limiting factor in ensuring appropriate quality maternal care. Basic training including, medical, nursing, midwifery and postgraduate education in Kenya has historically been of a high standard. However, the curriculum in pre-service medical and nursing schools has not changed to keep up with more recent developments in maternal care, such as Evidence Based Practice (EBP). Continuing Medical Education and updates for those already practising is limited. It is on the basis of these gaps and limitations that the Ministry of Health (MOH) with support from WHO began developing the National Guidelines for improving Quality Obstetrics and Perinatal Care. In response to the identified need for Standards of Care, a collaboration between the MOH and health professionals in Kenya and the United Kingdom has brought about the development of this document in line with the Kenya Quality Model (Appendix 1). A collaboration was formed by the MOH and Professional Associations of Kenya and UK, through the Safe Motherhood Know How Project. This project demonstrates the capacity of professional organisations to have a strategic role in providing safe obstetric care for women in Kenya. These Standards were developed by a multidisciplinary group of professionals from Kenya and the UK working together with the MOH, through a series of workshops and process of discussion and debate to achieve consensus. It is hoped they will serve as a basis from which further expansion and development will be possible. This document focuses on Standards for Obstetric Emergencies including: Haemorrhage, Sepsis, Pre-Eclampsia and Eclampsia, Obstructed Labour and Abortion. Clinical audit is the systematic and critical analysis of the quality of clinical care, including the procedures used for diagnosis, treatment and care, the associated use of resources and the resulting outcome and quality of life for the patient. A brief summary describing what clinical audit is and how it can be conducted is given in Chapter 4. Used in combination with Clinical Audit, we hope this document will contribute to improving the quality of maternal services.

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LIST OF ABBREVIATIONS AND ACRONYMS ANC Antenatal Clinic

APH Antepartum Haemorrhage

BEOC Basic Essential Obstetric Care

BP Blood Pressure OC Degrees Celsius

CCT Controlled Cord Traction

CEOC Comprehensive Essential Obstetric Care

CME Continuing Medical Education

D&C Dilatation and Curettage

DIC Disseminated Intravascular Coagulopathy

EDD Expected Date of Delivery

EOC Essential Obstetric Care

EWA Examination without anaesthesia

FP Family Planning

Hb Haemoglobin

HCP Health Care Provider

IEC Information, Education, Communication

IV Intravenous

LMP Last Menstrual Period

mls Millilitres

MVA Manual Vacuum Aspiration

PAC Post Abortion Care

PIH Pregnancy Induced Hypertension

PPH Postpartum Haemorrhage

Preps Preparations

PRN As necessary

ROU Rupture of Uterus

RPOC Retained products of conception

TBA Traditional Birth Attendant

X-match Cross-match

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DEFINITIONS

For the purpose of this document we have used the following definitions: APH - Ante Partum Haemorrhage This is bleeding from the genital tract after 24 weeks gestation and before delivery PPH - Post Partum Haemorrhage Bleeding from the birth canal after the birth of the baby until 6 weeks post partum amounting to 500mls or more or any amount that causes alteration of the maternal condition. Primary PPH: Bleeding from the birth canal after the birth of the baby within the first 24 hours of delivery with: perceived blood loss more than 500 ml and/or: clinical signs and symptoms of shock Secondary PPH: Genital tract bleeding after 24 hours delivery but within 42 days of delivery. (Most commonly between 10 and 14 days post delivery). It is characterised by bleeding more than what is considered normal lochia loss. Additionally, clinical signs of SHOCK may be present. Puerperal Sepsis This is an infection occurring at any time from the onset of rupture of membranes or labour and 6 weeks following delivery (or abortion). Temperature is 38OC or higher on two or more occasions.

With additional features such as: • pelvic pain or tenderness • odorous vaginal discharge • tender sub-involuted uterus Eclampsia This is characterised by generalised fits in a woman without a previous history of epilepsy. The woman usually has hypertension and proteinuria. The fits may occur during the antepartum, intrapartum or postpartum period. Prolonged Labour Prolonged labour is diagnosed when active labour with regular uterine contractions and progressive cervical dilatation, has gone on for more than 12 hours or The latent phase is more than 8 hours and/or: cervical dilatation in the active phase is less than 1 cm per hour. Obstructed Labour Labour is considered obstructed when, despite strong uterine contractions further progress is impossible because of mechanical reasons. Abortion This is the termination of a pregnancy (either spontaneous or induced) before 24 weeks gestation. WHO definition is: "The expulsion of foetus weighing less than 500g".

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Standards for Maternal Care Essential Obstetric Care Essential Obstetric Care is the term used to describe the elements of obstetric care needed for the management of both normal and complicated pregnancy, delivery and postpartum period. Essential Obstetric Care is defined for two different levels of the health care system: Basic Essential Obstetric Care The health facility should be able to provide: • Parenteral antibiotics, • Parenteral oxytocic drugs, • Parental anti-convulsants • Manual removal of the placenta • Manual Vacuum Aspiration (MVA) • Perform assisted vaginal delivery (e.g.

ventouse or vacuum). Comprehensive Essential Obstetric Care Includes all services in Basic Essential Obstetric Care plus • blood transfusion, • operative delivery under anesthesia i.e.

caesarean section. The Referral System This is the system that ensures a woman with obstetric complications is referred to the most appropriate health care facility to manage her condition in a timely manner. The referral system may start from the community to either dispensary, health centre or hospital where skilled staff are available to deal with the complication. A feedback mechanism in any referral system is important in enhancing its effectiveness. Quality improvement, standard setting and audit Audit criteria - systematically developed statements that can be used to assess the appropriateness of health care decisions, services and outcomes. They comprise measurable activities appropriate for the setting in which they are used and include: • Structure, • Process and • Outcome criteria.

Audit cycle - the process of defining and implementing best practice, carrying out an evaluation of practice through audit and repeating this after the implementation of change. Clinical audit - systematic and critical review of the quality of care whereby clinicians examine their own practice and results against agreed Standards of Care with a view to the modification of their practice where indicated - to improve quality. Clinical effectiveness - the extent to which specific clinical services or interventions do what they are intended to do. Clinical guidelines - systematically developed statements which assist in making decisions about appropriate health care for specific conditions - not intended to dictate an exclusive course of management or treatment. They are based upon available evidence or research. Clinical protocol - A way of describing exactly what must be done in specific situations. This often relates to high-risk situations. Evidence Based Medicine (EBM) - decisions made on a basis of contemporary research findings that are deemed as valid and reliable. EBM is classified as follows A, B, C: A = Very strong evidence: as in good

randomised controlled trials and systematic reviews.

B = Fairly Strong: good experiments and observations, non randomised.

C = More limited: weaker experiments and observations, case reports and expert opinion

Kenya Quality Model (KQM) integrates Evidence Based Medicine (EBM) through wide dissemination of public health and clinical Standards and guidelines with Total Quality Management (TQM) and Patient Partnership (PP) - These are the 3 pillars of KQM. (See Appendix 1, Page 35)

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Standards for Maternal Care Quality Improvement in Health Care: Quality Improvement in health care is a process involving the application of quality management principles and tools. This process leads to satisfaction of patient/client needs in a culturally appropriate way. Objective - an overall aim of care, or may be used as a broad statement of good practice based upon the best possible evidence. Policy - a statement that guides decision-making and constrains employees to stay within the bounds prescribed. Process - what needs to be done to achieve outcomes, alternatively called activities. Outcome - benefit, which will arise from meeting a Standard. Standard - sets out what is best practice and gives some idea of how that level of care is to be achieved. It is a basis for measurement by which the accuracy or quality of something is judged. Sometimes called the objective.

Standards statement - a concise description of a Standard or objective, ideally written in one short sentence. It may include guidance for its achievement or this may be included in an overall Standard e.g. in the structure, process, outcome model. Structure - elements that need to be in place or exist, such as resources or knowledge, in order to achieve outcomes and so meet Standards, alternatively called pre-requisites. Target - the extent to which an aspect of care can be achieved - maybe expressed as a percentage. Total Quality Management - a total organisational approach to meeting client expectations and needs. It involves all managers, employees and sectors.

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CHAPTER 1

Background

1.1 Introduction Maternal mortality has remained high in many developing countries - in sub Saharan Africa the maternal mortality ratio is estimated to be between 500 and 1500 per 100, 000 live births. In 1996, WHO estimated that globally at least 600,000 women die each year of pregnancy related causes and 99% of these women live in the less developed world. Approximately 90% of these deaths could have been prevented if timely and appropriate quality obstetric care had been provided. It is now recognised that all pregnant women are at risk of obstetric complications, therefore there needs to be universal provision of and accessibility to quality essential obstetric care. In Kenya, maternal care services are provided both in public and private facilities by nurses, midwives, doctors and clinical officers. The current nurse training (Kenya Registered Community Health Nurse) covers a broad curriculum, which includes midwifery skills. The clinical officers’ pre-service training covers basic obstetrics and a post basic course in reproductive health is now available. Medical Officers also cover obstetrics in their training with the opportunity to study Obstetrics and Gynaecology at postgraduate level. Within the current public sector services are provided at hospitals, health centres and dispensaries by all of the above professional staff. Antenatal services are available in the majority of health facilities with a high utilisation rate. Figures show that 92% of women attend antenatal clinic at least once during their pregnancy. However, the quality of service delivery is often not known. Nationally about 42% of births take place within health facilities. Figures vary between regions from 75% of births in Nairobi to only about 25% in Western Province.

Elements of basic essential obstetric care are expected to be available at all levels but comprehensive essential obstetric care is generally only available at hospitals. High quality health care is something all health professionals strive for. It ensures effective use of available resources and improves staff morale. It is recognized that a reputation for providing quality care attracts women to use a facility providing maternal services. This can only happen where careful planning, monitoring and supported motivated staff exists. In order to achieve this high goal of care it is important to know what is considered best practice according to the available scientific evidence and expert opinion both locally and generally. This is known as Evidence Based Medicine. Guidelines on providing quality care are written using best practice, which are in turn used to develop specific standards. Once standards are agreed on within a health facility they can be used as the basis for audit of that particular practice. Services should aim to provide a standard of care that results in the best possible outcome given the available resources and the care given should not inhibit utilisation of services. It is hoped that all health facilities or maternal care units pay attention to the issues raised within this document in order to improve the provision of quality care. Inter-professional collaboration together with a willingness to change are key elements of standard setting and undertaking continuous clinical audit.

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1.2 Rationale This document on Standards for Maternal Care is a response to the challenge to provide quality maternal care for women according to their needs. To develop these standards, a representative group of health care professionals who are committed to providing quality care for women during the antepartum, intrapartum and postpartum periods was established. A collaboration was set up between the Kenya Ministry of Health, and professional associations representing midwives, nurses, clinical officers and obstetricians in Kenya and the United Kingdom to demonstrate the capacity of midwifery, nursing and medical organisations to play a strategic role in improving maternal care through partnerships within and between countries. The organisations involved are: National Nurses Association of Kenya (NNAK), the Midwifery Chapter of Kenya, Nursing Council of Kenya; Clinical Officers Council of Kenya, Kenya Clinical Officers Association (KCOA), Kenya Obstetrics and Gynaecological Society (KOGS), The Royal College of Nursing (RCN), Royal College of Midwives (RCM), Royal College of Obstetricians and Gynaecologists (RCOG) and the Ministry of Health (MOH). The process for developing these standards was funded by the Department for International Development through the Professional Associations of Kenya and United Kingdom, Safe Motherhood Know How Fund Project, which is jointly coordinated by two representatives from NNAK and KOGS for the National Joint Steering Committee on maternal services. After discussion it was decided by the committee that the first set of Standards of Care to be developed would focus on Emergency Obstetric Care as this is a key area influencing maternal and perinatal mortality in Kenya. These standards have been prepared to facilitate evaluation of the quality of maternal health care provided at all levels of health facilities.

It is hoped that through the provision of quality maternal care there will be enhanced client and provider satisfaction and reduced maternal and perinatal morbidity and mortality. In order to achieve this, staff need to be motivated and updated in the importance of quality maternal health care and need an awareness of a woman’s needs regardless of her cultural or religious background. 1.3 Standards Standards for the provision of maternal care are written in order to indicate the quality of services that midwives, doctors, clinical officers and nurses should provide for women and their babies. Ideally health care providers themselves should decide what these standards should be, collaborating not only between professional groups, management and government but also with the clients or consumers of care. The Standards applied in this document are based on scientific evidence already compiled internationally and in Kenya. The Ministry of Health and WHO sponsored National Guidelines for Quality Obstetrics and Perinatal Care (to be published in 2003) provided the basis for this set of standards and is the source of the various protocols that are referred to in most of the standards. This approach is consistent with the Ministry of Health Department of Standards and Regulatory Services, which ensure that Standards of Care are evidence based, take into consideration the community perspectives and respect the individual’s rights. The Standards also conform to “Kenya Health Standards and Master Checklist for Health Services & Systems Monitoring and Evaluation (DSRS)” produced by the Ministry of Health, February 2002.

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Before commencing any audit of maternal care, it is essential to have clear standards against which practice can be measured. (And) It is for this purpose that the ensuing Standards were developed. Standards must express to the reader just what should be done, how the tasks will be carried out and what is expected in terms of achievement. Standards must be:

S - specific M - measurable A - achievable R - relevant T - timely

Each standard is set out as an objective followed by Structure, Process and Outcome criteria.

Structure criteria - describe what is needed to achieve the objective. It refers to resources in the health facility or community that are necessary to achieve the standard. This may include staffing, organisational arrangements, equipment and physical space. Process criteria - outlines what needs to be done to achieve the objective. It refers to actions and decisions to be undertaken by staff in conjunction with clients. Outcome criteria - refer to the desired result of implementing the process described.

The following Standards of Care were developed through a participating approach by multi-disciplinary teams. This list is not exhaustive and neither is it meant to be definitive. It is hoped the list will serve as a basis for audit and improvement of quality of care.

A. General Standards of Care 1. Every pregnant woman or woman in the

puerperium seeking health care, is attended to by a skilled health care provider within 30 minutes of arriving at the health facility.

2. A woman’s right to dignity is respected. 3. A woman’s right to privacy and

confidentiality is respected. 4. A woman’s right to information is respected. 5. A woman is given the choice of having a

companion with her during antenatal clinic, during labour and at the postnatal clinic.

6. Each woman seeking maternity care has a

clear and comprehensive obstetric medical record.

B. Management of Haemorrhage

1. Genital tract bleeding in pregnancy is recognized by women, their families and health care personnel as a danger sign and appropriate action is taken.

2. Every woman bleeding in pregnancy is

assessed within 30 minutes and initial treatment is commenced.

3. In all deliveries, there is active management

of the third stage of labour and preparedness for the management of Postpartum Haemorrhage.

4. The health care provider diagnoses and

manages or refers all cases of Postpartum Haemorrhage immediately.

5. Every woman with suspected retained

products of conception (including retained placenta) undergoes uterine exploration and/or manual removal of placenta within 1 hour of diagnosis.

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C. Management of Infection and

Sepsis 1. Every health care provider reduces the risk of

spreading infection by washing hands before and after every procedure.

2. All staff implement infection prevention

measures 3. Staff detect and document early signs and

symptoms of infection / sepsis

4. Clients with infection / sepsis are started on antibiotic treatment without delay.

5. Broad-spectrum antibiotics are always

available and accessible. D. Management of (Pre-)Eclampsia 1. All pregnant women recognize signs and

symptoms of (Pre-)Eclampsia and seek medical care.

2. All health care providers recognize signs and

symptoms of (Pre-)Eclampsia. 3. Every woman attending antenatal clinic has

her blood pressure measured, urine tested for protein and sugar, and the results recorded.

4. Every woman in labour has her urine tested

for protein and sugar on admission and her blood pressure measured and recorded.

5. Every woman has vital signs observed and

recorded ½ hourly for first 2 hours after delivery.

6. Health care providers take appropriate action

for clients with high blood pressure. 7. Every woman who has an eclamptic fit is

given appropriate care.

E. Management of Prolonged and Obstructed Labour

1. Every woman has access to skilled attendance

during delivery. 2. Pregnant women are encouraged to report to a

health care provider when labour commences and/or membranes rupture.

3. Every woman in labour in a health facility is

monitored with a partograph. 4. All women with suspected Rupture of Uterus

have initial treatment and preparations for operative delivery completed within 45 minutes – 1hour of the diagnosis and are referred or have surgery commenced within the same day.

5. Every woman with obstructed labour is

delivered or referred within 1 hour of diagnosis.

F. Management of Abortion 1. Every woman with an incomplete abortion

undergoes evacuation / manual vacuum aspiration or dilatation and curettage within 24 hours of diagnosis.

2. Every woman with an incomplete abortion,

who has had uterine evacuation or has complete abortion, is offered other reproductive health services before discharge.

3. Women and the communities know the

dangers of induced abortion. They are able to identify complications of abortion and access existing PAC services promptly.

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CHAPTER 2

Resources for Provision of Essential Obstetric Care

The following are a suggested list of resources that need to be in place to help provide acceptable standards of care for women in any health facility. These are the general criteria for each standard. Physical Resources: • Space/ - room for privacy • Comfortable waiting area (shade/shelter) • Water supply • Light source • Good drainage • Waste disposal system: incinerators/placenta

pit • Relevant protocols

Human Resources: Skilled health care providers deployed appropriately with adequate skills mix for each level of health facility. Health care providers have; • access to CME and updates in EOC. • positive attitude and good interpersonal skills. • supportive supervision and feedback. • commitment to improving care. • regular meetings to discuss client care.

Drugs Equipment and supplies For Basic Essential Obstetric Care Facilities

Drugs Drug Groups Examples of drugs

Antibiotics (broad spectrum) for IV/IM and oral administration

Includes Crystapen, Gentamycin and Metronidazole as minimum. Also erythromycin and or cephalosporin where available

IV fluids Normal saline, plasma expanders e.g. hemacel

Anticonvulsant (parenteral) Diazepam and/or Magnesium sulphate for IV/IM administration

Anti-hypertensives Methyldopa for oral administration and Hydralazine for IV/IM administration, Nifedipine preparations

Oxytocics Ergometrine, Oxytocin, Syntometrine, Misoprostol

Analgesics Paracetamol, Pethidine, Tramadol

Anaesthetics Lignocaine 1% and 2%

Anti-emetics Plasil, Phenergan

Anti spasmodics Hyoscine- N- butyl bromide

Antimalarials Sulfadoxine-pyrimethamine preparations, Quinine

Haematinics Folic acid, Ferrous sulphate

Others Tetracycline eye ointment 1% Potent Tetanus toxoid - cold chain maintained.

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Equipment: • Thermometer • Blood pressure machine and stethoscope • Foeto-scope • Equipment to measure/estimate haemoglobin concentration • Equipment for obtaining a blood sample • Manual Vacuum Aspiration equipment • Vaginal speculums (cuscos/sims) • Vaginal examination pack • Delivery pack • Suture pack • Infection prevention equipment (buckets with lids) • Emergency tray (complete) (See Appendix 4) • Oxygen cylinder and flowmeter • Ambu bag and mask • Vacuum extractor set (Depending on availability & level of Health Facility) Supplies: • Gauze • Cotton • Dipstix for urine • Gloves • Urinary catheters • IV fluids -needles, branula, giving sets • Sanitary Pads • Stationery - partograph, patient charts, notes, permanent registers Disinfectants: / Cleaning materials • Bleach as in jik and presept tablets • Hibitane • Cidex • Steranios • Soap (both powder and tablet) For Comprehensive Essential Obstetric Care facilities In addition to the Basic Essential Obstetric Care Equipment, the following are suggested: • Caesarian section set (see appendix 2) • Laboratory facilities: including equipment for grouping and cross-matching of blood • Blood transfusion - blood giving sets, branula • Anaesthetics services: Ketamine, marcaine, Various regional and general anaesthetics and the

relevant equipment (see appendix 2) • General surgical set ( see appendix 2) • D+C set (see appendix 2) • Simple ultrasound scanning machine • Emergency Tray with comprehensive list of Supplies & Equipment (see appendix 4)

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CHAPTER 3

Standards of Care with Structure, Process and Outcome Criteria

The selected Standards are grouped into six sections covering the five main obstetric complications that contribute to maternal deaths in Kenya as well as a section on general care. Every Standard is outlined in detail giving the structure, process and outcome criteria for each.

3A. General Standards of Care Although the selected Standards on Obstetric Complications are self evident, good quality care provides a woman with dignity during childbirth. It also tries to prevent the aspects of care that are disrespectful and unnecessary which will impact negatively on the confidence of women in using a specific facility.

High quality maternal health care can be provided in a variety of settings and does not necessarily refer to hospital-based treatment only. High quality care must be assured anywhere maternal health care takes place whether it is at home, or at the health facility level.

1. Every pregnant woman or woman in the puerperium seeking health care is attended to by a skilled health care provider within 30 minutes of arriving at the health facility.

Structure criteria Process criteria Outcome criteria

Appropriately skilled staff Appropriate staff are employed and deployed

When a woman arrives at the facility she is attended to by a skilled health care provider.

Accessible facilities Staffs are present in the facility or can be called immediately

Clear directions and signs Directions and signs are clearly displayed

Ground floor facilities (if possible)

Client flow plan in place All staff in the health facility are aware of the flow system

Delays at the health facility are reduced. Long queues become shorter.

Uniform and ID badges Uniform and ID badges are worn

Informed and alert Receptionist Women are directed to the appropriate unit

A fair and safe system of fee collection that does not prevent access to care

Fees are collected after the client’s condition has stabilized

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2. A woman’s right to dignity is respected

Structure criteria Process criteria Outcome criteria

Staff with positive attitude towards client and escort

Professionals and support staff take the needs of clients for dignity into account

Every woman attended to at the health facility feels she has been treated with dignity and respect.

Respectful staff Staff are polite and use appropriate language Clients are greeted by name Staff take into account cultural and religious background The client's opinion is sought Clients/escort are allowed to ask questions.

Specifically, they are: • Not addressed rudely • Not exposed unnecessarily • Listened to. Every woman knows who has attended to her and in what capacity.

Staff are uniformed and wear name badges

Staff introduce themselves to client by name Clients are given opportunity to choose their health care provider

Curtains and/or screens for privacy Screens and curtains are used and clients are covered with linen when examined

Linen to cover client

System for Laundering Adequate linen and curtains are stocked and laundered.

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3. A Woman’s right to privacy and confidentiality is respected Structure criteria Process criteria Outcome criteria

Private consulting area/ room History taking and examination is done in as much privacy as possible

Every woman attending the health facility feels her privacy and confidentiality has been respected.

Screens or curtains Adequate clean linen

Every woman is examined or attended to behind screens or curtains Women are never exposed unnecessarily

All women have been seen in an identified closed area or room.

Staff with appropriate positive attitude

Staff actively protect women's privacy and confidentiality

Uniformed staff with name badges Staff do not discuss or disclose client information to non-health care staff. Staff understand cultural and religious background of the client Every woman's opinion is sought.

4. A woman’s right to information is respected Structure criteria Process criteria Outcome criteria

Informed personnel Information is available and provided to clients/escort Counselling and support services available

Staff take time to explain: • Procedures • Diagnosis • Progress • Results • Options

A satisfied woman with better understanding of her care. Women are able to make informed choices

Private consulting room or area Clients are encouraged to ask questions about their condition and the suggested procedures

Staff give appropriate responses/answers Information is given in an open and friendly manner

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5. A woman is given the choice of having a companion1 with her during antenatal clinic, during labour and at the postnatal clinic2

Structure criteria Process criteria Outcome criteria

Private rooms/space are available Institutional guidelines allowing choice for companion

Companions are made to feel welcome The woman and family are informed on the benefits of having a companion Midwives and other staff are informed on the benefits of the women having a companion

Improved outcome of labour: • Decreased length of labour • Decreased need for analgesia Improved client and companion satisfaction

Clear information and choice available to companion

Clear rules are put in place e.g. companion not to feed the mother while in labour without instruction to do so by staff, respect privacy of other clients, not to administer any form of treatment etc. Monitor the rules on companionship. Reassurance for woman and her companion Companion provides continuous empathetic and physical support.

Randomised trials on support during labour have demonstrated that continuous empathetic and physical support during labour has a number of associated benefits: • Shorter labour • Less medication is required • Fewer APGAR Scores of less than 7 in newborns • Fewer operative deliveries

It also accelerates recovery, favours early bonding between mother and baby and decreases anxiety and depression during post partum period.

1 Can be partner, mother, mother-in-law, other relatives/friend, or TBA 2 Health care provider must not abdicate role to companion 6. Each woman seeking maternity care has a clear and comprehensive obstetric

medical record Professional Associations of Kenya and UK

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Structure criteria Process criteria Outcome criteria

Storage/Filing space Registers and registry facility including filing system Records to include: a) Client's own (e.g. Antenatal

card/Record) b) Hospital file Stationery including pens

Effective storage of Client records. Client information & procedures are documented accurately and immediately. Each record includes a minimum of: Name, Address, Identification No. Date and time, Next of kin History: Parity, age, presenting complaint and onset, LMP, EDD if pregnant, relevant past history and family history. Examination: General appearance Vital signs: temperature, BP, pulse, respiration Abdominal examination Condition of foetus Laboratory results

There is a comprehensive client record at the health facility, which is easy to retrieve. For antenatal care, each woman has her own record, which she brings with her on attendance to the health facility. Client waiting time is reduced Client data are available and used by staff allowing for improved treatment or follow up. Morbidity/Mortality patterns are clear.

Records personnel ‘In charge’ checks that records are present and up to date (on shift basis) Records are used for ‘handing over’ of client Entries are signed off Discharge notes include a follow-up appointment date, time and place Staff are able to retrieve records easily

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3B. Haemorrhage Haemorrhage is the leading direct cause of maternal morbidity and mortality accounting for 25% of all maternal deaths. Antepartum haemorrhage complicates 2-6% of all pregnancies. The majority of deaths due to postpartum haemorrhage occur within 4 hours of delivery. Dangers of bleeding in pregnancy include: • pregnancy loss • still births • anaemia • shock • maternal death

Additional important signs and symptoms include: • dizziness • pallor • abdominal pain • dyspnoea Communities/ families are encouraged to bring potential blood donors with them when escorting a woman to the health facility.

1. Genital tract bleeding in pregnancy is recognized by women, their families and

health care personnel as a danger sign and appropriate action is taken

Structure criteria Process criteria Outcome criteria

Contact with pregnant women and communities

Existing structures are used Women in the community are aware that any bleeding during pregnancy must be seen as a 'danger sign'.

IEC material on bleeding as a danger sign in pregnancy - visual/ audio, health talks.

All contact opportunities are used (e.g. churches / barazas) to provide information and have dialogue on the dangers of bleeding in pregnancy. Document all teachings and counselling activities conducted.

Health facility staff are aware that any bleeding during pregnancy, other than 'show', is considered to be abnormal

Community emergency transport system

A system of community emergency transport is available.

Delays associated with abnormal bleeding will be minimised.

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2. Every woman bleeding in pregnancy is assessed within 30 minutes and initial

treatment is commenced.

Structure criteria Process criteria Outcome criteria

Basic structure specifically: Couch and light source BP machine Stethoscope, Foetoscope Emergency tray with: IV cannula and fluids, blood giving set Specimen bottles Catheter Syringes and needles Blood donors Protocols for management of bleeding in pregnancy

For any woman presenting with bleeding in pregnancy: • A detailed history is taken • A complete physical examination is

carried out • The foetal condition is assessed • A speculum examination is carried

out to determine source of bleeding and status of cervix

• A digital vaginal examination is NOT performed unless placenta praevia is first excluded (e.g. by ultrasound examination)

Blood loss is estimated from history and examination and recorded Initial treatment is commenced consisting of: • IV cannula inserted • IV fluids administered as indicated

by vital signs • Blood transfused if IV fluids alone

do not stabilize client’s vital signs A senior member of staff is actively involved in client management.3 Flow chart instructions are followed. A decision is made about continued management. Referral is carried out if indicated. Uterus evacuated as indicated depending on gestation, severity of bleeding, fetal condition, cause of bleeding as determined by ultrasound or EWA. All findings are accurately documented on the client’s record.

Shock is prevented or detected and treated early in all cases of bleeding in pregnancy Reduced case fatality rate for bleeding in pregnancy Reduction in maternal and fetal/perinatal loss due to Haemorrhage

3 Depending on the health facility this could be senior or experienced midwife, clinical officer or doctor Professional Associations of Kenya and UK

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3. In all deliveries, there is active management of the third stage and preparedness for the management of Postpartum Haemorrhage

Structure criteria Process criteria Outcome criteria

Delivery set/tray to include an oxytocic and catheter

Previous obstetric history and risk factors for PPH are known to or identified by health care provider

Primary PPH is prevented Reduced blood loss in the third stage

An oxytocic is administered upon delivery of the anterior shoulder: • Syntocinon in cardiac clients or

women with hypertension • Ergometrine in all other cases The placenta is delivered by CCT after evidence of placental separation. The placenta is examined for completeness. The bladder is emptied before or immediately after delivery of the baby. Blood clots are expelled. The baby is put to the mothers breast immediately after delivery unless the Apgar score is low (<7)

Prevention of postpartum anaemia Prevention of secondary PPH are retained placenta or products Reduction in maternal mortality from PPH

Local anaesthetic and material to repair episiotomy and/or perineal injury.

The client is examined for injury of the genital tract and any injuries or an episiotomy are repaired within 30 minutes of delivery under local anaesthesia. Vital signs are observed and recorded

Clinical management guidelines and protocol

Mother cleaned and pad applied, made comfortable and given a warm drink Blood loss is estimated and recorded.

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4. The health care provider diagnoses and manages or refers all cases of Postpartum Haemorrhage immediately

Structure criteria Process criteria Outcome criteria

Clinical management guidelines

Flow chart displayed History is taken Physical examination done Blood loss estimated and clinical findings recorded

Reduced case fatality rate Reduced case morbidity

Flow chart for management of PPH

PPH diagnosed and cause identified Supportive treatment started: • Bladder emptied • 18-20 G cannula fixed • Group and Xmatch blood

obtained • IV fluid infusion commenced • Oxytocics administered • Transfusion done as necessary Senior member of staff actively involved immediately Definitive management instituted as per guideline and protocol

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5. Every woman with suspected retained products of conception (including retained placenta) undergoes uterine exploration and/or manual removal of placenta within 1 hour of diagnosis.

Structure criteria Process criteria Outcome criteria

Basic protocol on management of retained products of conception

Protocol displayed Bladder emptied 18 -20 G cannula fixed Grouped and X matched blood obtained IV fluid infusion commenced Senior member of staff actively involved immediately

Reduced case fatality rate Reduced incidence of case complications

Uterine exploration done Definitive management done as per protocol for clinical management is followed Oxytocics administered Observe for excessive lochia loss Transfusion done if necessary

Reduced need for transfusion

Referral system All care activities documented Reduced hospital stay

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3C. Infection and Sepsis Puerperal and neonatal sepsis are major causes of maternal and neonatal deaths. Unclean practices increase the risk of sepsis. Puerperal infection is more likely to occur after a caesarian section, prolonged labour, early rupture of membranes and frequent vaginal examinations. Strict infection

prevention measures during labour are therefore extremely important for preventing sepsis. A rise in temperature during the first few hours or days post delivery is a danger sign. Treatment with antibiotics should commence immediately when sepsis is diagnosed.

1. Every health care provider reduces the risk of spreading infection by washing

hands before and after every procedure. Structure criteria Process criteria Outcome criteria

Water supply, soap and towel (clean/disposable) or dryers

Nurse in charge ensures supplies are available and accessible

All staff practice hand washing before and after every procedure.

Money (budget) for the purchase of the above should be available

Hand washing is demonstrated to all new staff Staff wash hands before and after every procedure Water sources are properly maintained

Job aids in hand washing In Kenya, wall charts (job aids) demonstrating good hand washing technique are displayed

2. All staff implement infection prevention measures Structure criteria Process criteria Outcome criteria

Infection prevention protocols and guidelines Disposal facilities Environmental hygiene policy

Infection prevention protocols and guidelines are displayed Correct disposal of needles and syringes Correct disposal of sanitary pads Placenta and products of conception adequately disposed off.

Cross-infection is reduced Length of client stay due to infection is reduced

Infection control team

Labour wards cleaned, minimum of 2 times a day with a disinfectant All mattresses cleaned between clients and at the beginning and end of each day Infection control team meets regularly and audits practice Infection surveillance is practiced regularly

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3. Staff detect and document early signs and symptoms of infection / sepsis Structure criteria Process criteria Outcome criteria

Updates on infection prevention and management for staff on postnatal wards

Training updates on detection and management of infection are carried out regularly

Cases of infection detected early before progression to sepsis

Thermometer Client record

The following are checked and recorded daily: • Vital Signs - temperature

twice a day • Uterine involution • Nature/quality of lochia • Breasts • Episiotomy, tear, perineum

Referral system Protocols for the management of sepsis are used correctly

4. Clients with infection / sepsis are started on antibiotic treatment without delay*

Structure criteria Process criteria Outcome criteria

Infection management guidelines and protocols Laboratory facilities

Clinical guidelines for management of cases of sepsis are followed Investigations: • Urine for microscopy • Blood for: HB %, WBC

total/differential blood cultures • Malaria parasites • High vaginal swab • Swabs from wound sites

All clients with recognized infection have broad spectrum antibiotics commenced within 30 minutes of diagnosis Hospital stay shortened Reduced case fatality rate for clients with sepsis

Updates on use of antibiotics Antibiotics available Documented observations

Broad spectrum antibiotics administered IV

Enabling policy on drug prescription with clear guidelines and mandate for nurse midwives

Treatment for root cause initiated

* Nurse-Midwives should be able to commence antibiotics (even if not allowed to prescribe). The doctor to

come at earliest opportunity to prescribe and continue antibiotic therapy.

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5. Broad-spectrum antibiotics are always available and accessible.

Structure criteria Process criteria Outcome criteria Procurement system to include: distribution, constant supply, timely replacement

Stocks are checked by the ‘in charge’ on a regular basis. Drugs are procured regularly

Reduction in delay in commencing treatment for clients who need antibiotics. Reduction in hospital stay

Accessible secure storage system There is 'handing over' of drugs and keys to drug cupboards Everyone knows who has the keys to the drug cupboard and who is allowed to give antibiotics.

Requisition forms and balance books (both internal and external) Broad spectrum antibiotics

Requisition forms and drug books are completed and checked

3D. (Pre-) Eclampsia (Pre-) Eclampsia can be a serious complication in pregnancy especially in combination with proteinuria. Eclampsia causes an estimated 12% of maternal deaths worldwide every year.

1. All pregnant women recognize signs and symptoms of (Pre-) Eclampsia and seek medical care.

2. Structure criteria Process criteria Outcome criteria

Health education sessions on PIH to relevant individuals and communities

Pregnant women at the ANC are taught about the signs, symptoms and consequences of PIH. Contact opportunities are used (e.g. churches /funerals) to provide information/ dialogue on the signs, symptoms and consequences of PIH

Women can list signs, symptoms and consequences of PIH Women with signs and symptoms of PIH present in the health facility within 24 hrs

Pamphlets/audiovisuals/ radio programs on PIH

Information material is disseminated Communities mobilized to initiate a functional transport system

Functional community emergency transport in place

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2. All health care providers recognize signs and symptoms of (Pre-) Eclampsia Structure criteria Process criteria Outcome criteria

Update program on PIH for all health care providers

Update sessions on PIH for HCPs carried out regularly and the log of activities kept

Improved knowledge on signs and symptoms of PIH among health care providers

Training material on PIH Early detection of PIH by health care providers

3. Every woman attending antenatal clinic has her blood pressure measured, urine

tested for protein and sugar, and the results recorded. Structure criteria Process criteria Outcome criteria

Basic ANC record card ANC record book ANC profile book

Protocol for management of PIH is displayed BP is taken with stethoscope and recorded

(Pre-) Eclampsia is diagnosed early Incidence of eclampsia is reduced

Toilet/latrine Urine specimen containers dipstix

Urine is collected, tested with dipstix and results are recorded

Flow chart for diagnosis and management of (Pre-) Eclampsia

Clinical management protocol is applied

One aim of antenatal care is to detect pre-eclampsia in the hope that the onset of serious complications (including eclampsia) can be delayed or prevented. 4. Every woman in labour has her urine tested for protein and sugar on admission and

her Blood Pressure measured and recorded. Structure criteria Process criteria Outcome criteria

Basic: • blood pressure machine • dipstix

Protocol for diagnosis and management of (Pre-) Eclampsia

Diagnostic protocol displayed in labour ward Blood pressure taken & urine4 tested for protein for all women in labour at admission Results are documented.

(Pre-) Eclampsia is diagnosed early and managed according to protocol Incidence of eclampsia is reduced Complications of (Pre-) Eclampsia reduced

4 If membrane ruptured, catheter specimen obtained Professional Associations of Kenya and UK

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5. Every woman has vital signs observed and recorded ½ hourly for the first 2 hours

after delivery

Structure criteria Process criteria Outcome criteria

Basic Protocols

Vital signs taken and recorded (BP, pulse, respiration, temperature) ½ hourly Protocols followed

Immediate postpartum (Pre-) Eclampsia diagnosed Incidence of eclampsia is reduced Complications of eclampsia reduced

6. Health Care Providers take appropriate action for clients with high blood pressure

Structure criteria Process criteria Outcome criteria

Revised curriculum Clear diagnostic charts in work areas (antenatal clinic, labour wards). Protocol on management of hypertensive disease in pregnancy a

Nurse-Midwives, Clinical Officers and Doctors updated on the management of hypertensive disease in pregnancy

Reduction in delay of management of women with high blood pressure. Reduction in case morbidity and mortality Incidence of (Pre-) Eclampsia and eclampsia is reduced

Enabling policy for midwives b Hypertensive drugs available

Nurse-Midwives, Clinical Officers and Doctors prescribe and dispense drugs for hypertensive disease in pregnancy as soon as PIH diagnosed

Empowered Nurse-Midwives and Clinical Officers

a Cut-off points for blood pressure clearly established and agreed b The implementation of this standard by midwives will require some policy changes to allow midwives to

prescribe drugs such as anti-hypertensive drugs e.g. Methyldopa

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7. Every woman who has an eclamptic fit is given appropriate care.

Structure criteria Process criteria Outcome criteria

Ioline & fluids Client properly positioned to ensure clear airway

Catheter & Urine bags, patella hammer

IV Cannula fixed

Suction machine and emergency tray (see Appendix 4)

Anticonvulsant drugs are given to ensure the client is well sedated but rousable by administering diazepam or magnesium sulphate as per protocol and hydralazine for raised blood pressure

Observation equipment • Thermometer • Blood Pressure Machine • Charts Fluid input and output chart

Vital signs checked and recorded ¼ hourly Fetal condition is monitored ¼ hourly Pelvic examination is done to assess labour and determine mode of delivery Urine output is monitored via an indwelling Foley's catheter connected to urine bag. A strict fluid chart is maintained

High quality care for women with eclampsia Complications of eclampsia reduced Case fatality reduced Perinatal mortality reduced

Management protocol on (Pre-) eclampsia

Clinical management as per protocol is followed

Diazepam together with IV hydralazine as the anti-hypertensive drugs of choice are generally used in Kenya for treatment of eclampsia. However, studies have shown that Magnesium Sulphate is the most effective anticonvulsant and is now the recommended drug of choice. It is currently not widely available in Kenya.

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3E. Prolonged and Obstructed Labour 8% of all maternal deaths in developing countries (including Kenya) are due to obstructed labour. This is an underestimation of the problem because deaths due to obstructed labour are often classified under other complications.

1. Every woman has access to skilled attendance during delivery.

Structure criteria Process criteria Outcome criteria

Midwives Communities are educated on the value of skilled attendance at delivery

All women are delivered by a skilled attendant

Community partnership

Clinical officers trained in obstetrics System of effective TBA supervision

There is good communication between the health facility and the community There is good and free communication between the health facility staff e.g. TBAs & community

Obstetric complications are identified early Women with obstetric complications are referred or managed without delay.

2. Pregnant women are encouraged to report to a health care provider when labour

commences and/or membranes rupture.

Structure criteria Process criteria Outcome criteria

User friendly maternity services Clear community health financing strategies IEC material on symptoms and signs of labour - hand bills, posters System for community education Community transport systems

Every pregnant woman is educated on: • Symptoms and signs of labour and

rupture of membranes • Advantages of skilled

assistance at delivery • Disadvantages of delivering

without skilled assistance Communities are educated on: • Advantages of skilled

assistance at delivery • Disadvantages of delivering

without skilled attendance • Health facilities are client-

friendly places • Need for functional emergency

transport arrangement

Reduced delay in reporting to health facility when in labour

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3. Every woman in labour in a health facility is monitored with a partograph.

Structure criteria Process criteria Outcome criteria

Guidelines on use and interpretation of partographs Partographs

Guidelines on partographs are available HCPs rule out abnormal lie, malpresentations and malpositions in all mothers in active labour. Pelvic assessment is done in labour Labour observations are done and plotted on a partograph Partograph is correctly interpreted Action taken immediately, as necessary, on detected abnormalities

Early detection of prolonged labour and management commenced without delay Other complications of labour detected and treated early

4. All women with suspected Rupture of Uterus have initial treatment and

preparations for operative delivery completed within 45 minutes – 1 hour of the diagnosis and are referred or have surgery commenced within the same day.

Structure criteria Process criteria Outcome criteria

Staff educated Signs & symptoms of ROU are clearly displayed Clinical management protocol present Community, TBAs and women educated on signs & symptoms of ROU Referral protocol Functional community emergency transport arrangement

Clinical management protocol displayed Client examined and diagnosis confirmed Staff, TBAs and community aware of signs & symptoms of ROU and need for immediate action Resuscitation commenced immediately Client admitted or referred as per protocol Definitive treatment given

Reduced delay in management of women with suspected ROU. Reduced delay in referral for women with suspected ROU. Reduction in case fatality rate.

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5. Every woman with obstructed labour is delivered or referred within 1 hour of the

diagnosis.

Structure criteria Process criteria Outcome criteria

Functional emergency transport Diagnostic flow chart Clinical management protocol

Diagnostic flow chart and clinical management protocol is displayed History is taken, client examined and findings recorded Diagnostic flow chart is applied Supportive treatment and theatre preparations are started as soon as diagnosis is made or suspected Client is operated or referred as per protocol Referral system functions effectively A system of community transport is available and shown to the community Within the community, women and TBAs are aware of the signs & symptoms of obstructed labour

All women with obstructed labour are delivered or referred within 1 hour of diagnosis Reduction in morbidity and mortality due to obstructed labour

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3F. Abortion Complications of unsafe abortion are a major cause of unnecessary maternal morbidity and mortality. In Kenya, abortion complications are estimated to contribute to 30% of maternal deaths annually. 1. Every woman with an incomplete abortion undergoes evacuation / manual vacuum

aspiration or dilatation and curettage within 24hours of diagnosis.

Structure criteria Process criteria Outcome criteria

Basic structure Room set aside for evacuation and/or minor surgery Guidelines and protocols for management of incomplete abortion

Clinical guidelines /protocols displayed History taken, client examined and diagnosis made Uterus evacuated using MVA or D&C as per protocol Antibiotics given Client allowed to rest

Reduced incidence of case complication Reduced delay in case management Reduced case fatality rate

2. Every woman with an incomplete abortion, who has had uterine evacuation or has complete abortion, is offered other reproductive health services before discharge.

Structure criteria Process criteria Outcome criteria

Room for counselling Protocol for management Guidelines Counselling services FP services Screening services for STI and cervical cancer Follow up system

Counselling given FP methods provided Client assessed for other reproductive health problems Clients offered or referred to other reproductive health services

Reduced recurrence of abortion Increased utilization of other reproductive health services Reduced case complication rate

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3. Women and the communities know the dangers of induced abortion. They are able to identify complications of abortion and access existing PAC services promptly.

Structure criteria Process criteria Outcome criteria

Opportunities for contact with women and communities IEC material on abortion Community emergency transport system

Existing structures are used All contact opportunities are used (e.g. churches / barazas / women group meetings) to provide information and dialogue on: • The signs and symptoms of

spontaneous abortion • The dangers of induced abortion • The existing PAC services. A system of community emergency transport is available and known to the community

Women and the community, in general, can name: • The signs and symptoms

of spontaneous abortion • The dangers of induced

abortion

• Existing PAC services Delays in initiation of PAC services are minimized

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CHAPTER 4

Clinical Audit What is Clinical Audit? Clinical audit is the systematic and critical review of the quality of care where health care providers examine their own practice, attitudes and knowledge against agreed standards with a view to changing their practice to improve or maintain quality services. Standards are statements of the best quality of care that a service aims to offer. They are based on available evidence, which can be either from clinical trials or, in the absence of such studies, professional consensus of what is good practice. The standards, therefore, represent the benchmark against which actual practice is measured. Clinical audit is the process that allows continuous monitoring of current practice against agreed standards. The process is described in Figure 1 on Pg. 30. The process of clinical audit embodies the concept of continuous quality improvement. At some stage, the previously set standard may either be changed due to new evidence or, having been achieved, be made more stringent. Types of Clinical Audit There are several types of Clinical Audit including:

• Using standards based on structure, process and outcome. This is the approach adopted in this manual. This has also been called “Criterion-based audit”.

• Critical incident or near miss analysis. This

approach entails regular reviews of the actions taken in specific life-threatening clinical situation, for example, rupture of the uterus, and a panel of professionals agree on the performance level.

• Confidential enquiries, for example, regional or national audit on maternal mortality

• National monitoring. Advantages of Clinical Audit include:

• It allows available evidence to inform clinical practice

• It fosters multi-professional approach to problem solving

• It fosters internal ownership of quality improvement

• It is part of quality improvement in health care provision

• It allows unbiased assessment of quality of care without apportionment of blame or fear of victimization.

In conclusion, the audit process requires:

• Collaboration between professional groups • Commitment to improve quality of care • Multi-professional clinical leadership and

ownership • Agreement on best practice and priorities • Management and political support.

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The Process of Clinical Audit Standards based or criterion based clinical audit usually consist of five steps (see fig 1 below):

Step 1: Agree on Standard of Care

This step consists of the following:

• Choose a topic for audit e.g. obstetric haemorrhage

• Enlist support of staff involved preferably from a variety of backgrounds

• Review available evidence for the best practice

• Jointly develop the standard for best practice (with components: objectives

and structure, process and outcomes criteria)

This is the process that was followed in developing the Standards outlined in this document.

Fig 1: The Clinical Audit Cycle / Process

Step 1:

Agree on Standard of Care

Step 2:

MeasureStep 5:

Re-evaluate practice

Step 4: Agree on changes to bemade to achieve best

practice

Step 3: Measure against agreed

standard of best practice and feedback

findings

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Step 2: Measure Current Practice This step consists of the following:

• Identify the methods of data collection such as client interview, direct observations, questionnaires or use of checklists

• Develop data collection tools5 and agree who will collect the information. An audit team should be composed of independent professional colleagues to avoid conflict of interest between personnel carrying out the audit and those being audited.

• Identify the sources of data and methods for sampling. The issues of how representative, valid and reliable the data collected are, become important. Sometimes it is necessary to consult experts in this area.

• Collect, summarize and analyze data. For audit purposes, simple calculation of percentage of cases where the criteria were met is adequate.

Step 3: Measure against agreed standard of best

practice and feedback findings This step consists of the following:

• Report findings to all staff in unit or facility

• Commend progress and draw attention to areas where changes are needed

• Determine the extent of achievement of the criteria by next audit visit.

Involve the wider staff i.e. domestic workers, records, clerks, technicians etc. in developing action plans to implement changes (what changes are needed, what actions need to be done, by who, when and what extra resources are needed). 5 Forms specially designed to collect information.

Step 4: Agree on changes to be made to achieve

best practice This step consists of the following:

• Name the individuals who will effect and monitor changes

• Determine the pace of change • Hold regular meetings to maintain

motivation and sustain change. Step 5: Re- evaluate practice This step is essentially the same as step 2. The only difference is that it measures the practice after the changes have been made and are compared with the baseline practice and the set standard. The findings and feedback after this may still identify deficiency, in which case more changes for improvement will be needed. If the findings meet the required standard then the subsequent regular measurements may be scheduled at greater intervals to maintain the high quality. Alternatively, the level of achievement can be made more stringent.

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Is Clinical Audit Different From Research? Readers sometimes assume that clinical audit and research are the same thing. However it is important to understand the differences. Research is about establishing the right thing to do whereas clinical audit ensures that the right thing is actually done. Research is about creating new knowledge; for example finding out whether new treatments or procedures work and whether certain treatments or procedures work better than others. Research adds to scientific knowledge, which has universal

application and forms the basis of the agreed national clinical guidelines. Standards or best practice are derived from national guidelines. Clinical audit enables health care providers to monitor and improve practice in specific situations as well as enhancing continuing medical education. It can contribute to developing a greater sense of clinical accountability, openness, inter-professional understanding and sensitivity to clients’ needs.

Some differences between research and audit are: Research Clinical Audit Creates new knowledge about what works and what does not work – determines the right thing to do

Answers the question: “are we following evidence based best practice?” – determines if the right thing is actually done.

Is based on a hypothesis Measures against Standards

Is usually carried out on a large scale over a prolonged period but has a finite end

Is usually carried out on a relatively small population over a short time span and is repeated in cycles

May involve patients/clients receiving a completely new treatment

Does not usually involve a completely new treatment

May involve experiments on clients Does not involve anything being done to clients beyond their normal clinical management

May involve patients/clients being allocated to different treatment groups

Does not involve allocation of patients/clients to different treatment groups

Is based on a scientifically valid sample size (although this may not apply to a pilot study)

Depends on circumstances and may be pragmatically based on a small sample

Despite the differences outlined above there are also a few similarities to be considered. The similarities between research and clinical audit include: • Audit and research involve answering a specific question relating to quality of care • Both can be carried out prospectively and retrospectively • Both involve careful planning • Both activities should be professionally led.

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References

Bristol United Hospitals Trust. 2001 Clinical Audit “How to - -” booklets, Available online from http://www.ubht.org.uk/clinicalaudit/ Buckley E.R. 1997 Delivering quality in midwifery. London, Bailliere Tindall. Benbow A., Maresh M, Royal College of Obstetricians and Gynaecologists Clinical Audit Unit, Semple D. 1997 Effective Procedures in Maternity Care suitable for Audit, London: RCOG Press, and available online from http://www.rcog.org.uk/ Graham, W. et al. 2000 Criteria for clinical audit of the quality of hospital-based obstetric care in developing countries, Bulletin of the World Health Organisation, 78, 5, 614-620. Hulton LA, Matthews Z. and Srones RW. 2000 A Framework for Evaluation of Quality of Care in Maternity Services, Southampton: University of Southampton. Maresh M. 1999 Auditing Care, Chapter in Marsh G. and Renfrew M. eds. Community-based Maternity Care, Oxford: Oxford University Press. Ministry of Health, Kenya. 1996 National Reproductive Health Strategy, 1997 –2010. Ministry of Health, Kenya. 1997 A Question of Survival? Review of Safe Motherhood, Prepared by: Graham WJ. and Murray SF., Division of Primary Health Care. Ministry of Health, Kenya. 1998 Implementation Plan for National Reproductive Health Strategy, 1999 –2003. Ministry of Health, Kenya. 2002 Kenya Health Standards and Master Checklist for Health Services & Systems Monitoring and Evaluation (DSRS), February. Ministry of Health, Kenya, University of Nairobi, Population Council. 2002 Essential Obstetric Care Manual for Health Service Providers in Kenya, March. Ministry of Health Kenya, unpublished, A National Guide to Quality Obstetric and Perinatal Care for Service Providers in Kenya, draft April 2002. Morrell C. and Harvey G. 1999 The Clinical Audit Handbook, London: Bailliere Tindall RCOG. 2001 Guidance for the Development of RCOG Green-top Guidelines, http://www.rcog.org.uk/medical/greentopguide.html 25 05 2001. Safe Motherhood Inter-Agency Group 1998 Fact Sheets, Available online from http://www.safemotherhood.org/init_facts.htm Smith R. 1992 Audit and Research. British Medical Journal, 305, 905-906.

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Turnbull A. and Chamberlain G. eds. 1995/2001 Obstetrics, Edinburgh: Churchill Livingstone. Wagaarachchi W et al. 2000 Improving quality of obstetric care through criterion-based clinical audit. A practice field guide (unpublished pilot version). Aberdeen, The Dugald Baird Centre. Western General Hospital. 2001 Introduction to Clinical Effectiveness. Available online from http://www.org.wghaudit.demon.co.uk/ World Health Organization. 1994 Mother and Baby Care Package; Implementing Safe Motherhood in countries, Geneva: WHO. World Health Organization, South East Asia Region. 1999, Standards of Midwifery Practice for Safe Motherhood, Vol. 1-4, New Delhi: WHO SEARO. World Health Organization. 1999: A Joint WHO / UNFPA / UNICEF / World Bank Statement World Health Organization. 2000: IMPAC: Managing Complications in Pregnancy and Childbirth: a guide for midwives and doctors, Geneva: WHO.

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APPENDICES

Appendix 1 KENYA QUALITY MODEL (KQM) Quality Improvement in Health Care (QIHC)

12. Results: - Users/clients - Performance of facility and PHC Programmes - Staff

1. Leadership - supervision 2. Staff; 3. Policy; S&G 4. Facility; 5. Supplies 6. Equipment; 7. Transport; 8. Referral

Quality Improvement is a process…

• Leadership to provide guidance and motivation to Quality Improvement

• Involvement of people

and stakeholders

…to improve adherence to standards and guidelines based on EBM

• Systems approach to

Management • Process orientation • Continuous improvement • Factual approach to

decision making (link to HMIS, HIS Checklist

…to improve structure-process-outcome by applying Quality principles and tools

• User/patient/client orientation

…to satisfy patients’ / clients’ needs in a culturally appropriate way

- Application of Quality tools (e.g. HSI Checklist – self-assessment)

principles and

11. Process - Health Service: Client-Provider-Interaction - Continuous QI

STRUCTURE - PROCESS - OUTCOME

Involvement Representati no Participation

Management of Quality Health Services

DefinitionQuality principlesRoles and Responsibilities

Actors QIHC

HSI

Leadership: Standards & Guidelines Capacity Building M&E system Regulation

Quality Assessment with HSI Checklist PMO

Users/patients/clients

Community

Districts

DSRS

PP*

TQM*

EBM*

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*Abbreviations: EBM = Evidence-based Medicine; TQM = Total Quality Management; PP = Patient Partnership Source: Kenya Health Standards and Master Checklist for Health Services and Systems Monitoring and Evaluation

Department of Standards and Regulatory Services (DSRS), February 2002

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Appendix 2

Details of Equipment

1. Delivery Pack (for all levels)

• Kidney-dish (2) • Artery forceps (2) • Cord-cutting/blunt-ended scissors

(1) • Cord ties (2)

• Gloves (2 pairs) • Plastic sheeting (1) • Gauze swabs (4) • Cloth (1)

2. Perineal/Suture/Cervical Repair Pack (for all levels)

• Sponge forceps (2) • Artery forceps

Large (1) Small (1)

• Needle holder (1)

• Stitch scissors (1) • Dissecting forceps, toothed (1) • Vaginal speculum, large (Sims) (1) • Vaginal Speculum (Hamilton Bailey) (1)

3. Obstetric Laparotomy/Caesarean Section Pack (for hospital)

• Stainless steel instrument tray with cover (1)

• Towel clips (2) • Sponge forceps, 22.5 cm (6) • Straight artery forceps, 16 cm (4) • Uterine haemostasis forceps, 20

cm (8) • Hysterectomy forceps, straight,

22.5 cm (4) • Mosquito forceps, 12.5 cm (6) • Uterine tenaculum forceps, 28 cm

(1) • Needle holder, straight, 17.5 cm

(1) • Surgical knife handle

No. 3 (1) No. 4 (1)

• Triangular point suture needles, 7.3 cm, size 6 (2)

• Round-bodied needles No. 12, size 6 (2)

• Abdominal rectractor, size 3 (2)

• Abdominal rectractors, double-ended (Richardson) (2)

• Curved operating scissors, blunt pointed (Mayo), 17 cm (1)

• Straight operating scissors, blunt pointed (Mayo), 17 cm (1)

• Scissors, straight, 23 cm (1) • Suction nozzle (1) • Green-Armitage forceps (2) • Suction tube, 22.5 cm, 23 French

gauge (1) • Intestinal clamps, curved (Dry), 22.5

cm (2) • Intestinal clamps, straight, 22.5 cm

(2) • Dressing (non-toothed tissue) forceps

15 cm (2) 25 cm (2)

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4. Neonatal Resuscitation Pack

• Mucus extractor (1) • Infact face mask (2 different

sizes) • Ventilatory bag (1) • Suction catheter Ch 12 (2) • Suction catheter Ch 10 (2)

• Infant laryngoscope with spare bulb and batteries (1)

• Endotracheal tubes 3.5 (1) • Suction apparatus: foot-operated or

electrically operated

5. Basic Equipment for Uterine Evacuation

• Vaginal speculum (Sims) (1) • Vaginal speculum (Cuscos) (1) • Sponge (ring) forceps or uterine

packing forceps (1) • Single tooth tenaculum forceps

(1) • Long dressing forceps (1) • Uterine dilators, sizes 13-27

(French) (1set) • Sharp and blunt uterine curettes,

size 0 or 00 (1) • Malleable metal sound (1)

Manual Vacuum Aspiration • Basic uterine evacuation instruments

PLUS: • Vacuum syringes (single or double

value) • Silicone lubricant • Adapters • Flexible cannulae, size 4 to 12 mm

6. Equipment for Anaesthesia (for hospital)

• Anaesthetic face masks • Oropharyngeal airways • Laryngoscopes • Endotracheal tubes:

- With cuffs (8mm and 10mm) - Intubating forceps (Magill): in

an emergency, ovum forceps can be used instead

- Endotracheal tube connectors: 15mm plastic (can be connected directly to the breathing valve) (3 for each tube size)

• Spinal needles (range of sizes, 18-gauge to 25-gauge)

• Suction apparatus: foot-operated or electrically operated

• Anaesthesia apparatus (draw-over system)

• Oxygen cylinder, with manometer and flowmeter (low flow)

• Tubes and connectors

7. Vacuum extractor set (with Silicon/Plastic caps)

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Appendix 3

Contributors

NAME DESIGNATION ORGANIZATION

1 Teresia Chindia Clinical Officer Clinical Officers Council

2 Lisa Vallely Safe Motherhood Representative DfID

3 Robert Osiemo National Chairman Kenya Clinical Officers Association (KCOA)

4 Tobias Kichari Member KCOA

5 Dr. Eunice Cheserem Obstetrician KEMWA

6 Catherine Nyangol Midwife Kenyatta National Hospital

7 Stephen Gacheru Midwife Kenyatta National Hospital

8 Dr. Joseph Karanja Chairman of KOGS, Project Coordinator

Kenya Obstetrical & Gynaecological Society (KOGS)

9 Dr. Patrick Ndavi Member of Council KOGS

10 Dr. Edwin Were Head, Department of Reproductive Health, Moi University

KOGS / TRP Kenya

11 Michael Obwaku Clinical Officer Malava Sub-District Hospital

12 Nancy Waweru ACNO M.O.H – Division of Reproductive Health

13 Dr. Josephine Kibaru Reproductive Health Head M.O.H – Division of Reproductive Health

14 Chris Rakuom Assistant Chief Nursing Officer M.O.H – DSRS/Division of Nursing

15 Dr. Tom Mboya Head, Department of Health Standards and Regulatory Services

M.O.H

16 Donald Epaalat National Chairman NNAK

17 Evelyn Mutio Hon. National Secretary of NNAK, Project Coordinator

NNAK

18 Shehn Talib Nurse-Midwife NNAK / TRP Kenya

19 Heme Ndung’u Safe Motherhood Know-How Project Coordinator

NNAK

20 Danny Mwangi Vice - Chairman NNAK

21 Annie Mwangi Senior Nursing Officer NNAK / Midwives Chapter/KNH

22 Margaret Bunde Midwife NNAK / Midwives Chapter

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NAME DESIGNATION ORGANIZATION

23 Grace Kongoro Nursing Officer Nursing Council of Kenya

24 Dr. Esther Muia Programme Associate in R.H Population Council

25 Wilson Liambila Programme Officer Population Council

26 Charlotte Warren Staff Associate Population Council

27 Dr. Judith Bwonya District Medical Officer of Health

Kakamega District

28 Repha Mwenesi Midwife in Charge - Maternity Unit

Provincial General Hospital, Kakamega

29 Mary Aluku Midwife Provincial General Hospital, Kakamega

30 Nelly Kamau Midwife Pumwani Maternity Hospital

31 Nancy Amisi Midwife Pumwani Maternity Hospital

32 Dr. Felix Musili Medical Superintendent / Obstetrician

Pumwani Maternity Hospital

33 Jane Shihemi Acting Matron Pumwani Maternity Hospital

34 Dr. Blasio Omuga Medical Superintendent Pumwani Maternity Hospital

35 Gillian Barber UK Technical Resource Person RCN, RCM

36 Dr. Nynke van den Broek UK Technical Resource Person RCOG

37 Godfred Amanya Clinical Officer Sabatia Health Centre

38 Dianah W. Mwangi Project Administrator (From July 2002)

Safe Motherhood Know-How Project

39 Peris Kibera Project Administrator (June 2001- June 2002)

Safe Motherhood Know-How Project

40 Prof. Rachael Musoke Associate Professor of Paediatrics

University of Nairobi

41 Dr. Matt Carty Senior Vice President RCOG, UK

42 Mrs. Frances Day-Stirk Professional Officer RCM, UK

43 Mrs. Caroline Hyde-Price International Secretary RCN, UK

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Appendix 4

Emergency Tray with Comprehensive List of Supplies & Equipment

• Resuscitation table

• Atropine

• Diazepam

• Naloxone

• Calcium Gluconate Injection 10% in 10mls

• Dextrostix • Volume/Plasma expanders (5% albumin / dextran / NS)

• Phenobarbitone

• Vitamin K (IM, IV, oral)

• Acyclovir (topical preparation, suspension, iv)

• Potassium Chloride Injection 10mls

• Sodium Bicarbonate (4.2% and 8.4%)

• 10% and 50% glucose

• Adrenaline (1:10,000 solution)

• Ergometrine injection 500 mcg/ml

• Oxytocin (injection) 50 units/ml

• Oxygen supply

• Ambu bags (adult and baby)

• Face masks (adult and baby)

• Suction Apparatus

• Laryngoscope with blades, handles

batteries

• Endotracheal tubes (sizes 2.5, 3.5, 4.0)

• Disposable gloves

• Hypodermic needles (different sizes)

• Syringes (different sizes)

• Tubes for collecting blood samples

• Forceps

• Vacuum extractors

• Nasogastric tubes

• Delivery kit

• Meconium aspirators

• Warm clean and dry linen

• Source of heat

• Receptacle for soiled linen

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i